Cardiac Ventricular Geometry Restoration Device and Treatment for Heart Failure

ABSTRACT

Methods for cardiac ventricular restoration include delivering an implantable expandable device into the ventricle via a catheter. The expandable device is anchored either to the wall of the left ventricle or to the inter-ventricular septum and then expanded. When expanded, the device assumes a size and shape which fills the lower portion of the ventricular cavity restoring the normal volume and ellipsoid shape of the remaining portion of the cavity and favorably altering myocardial oxygen demand and wall stress.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Ser. No. 11/070,789,filed Mar. 2, 2005, which is hereby incorporated by reference herein inits entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates broadly to methods and apparatus for performing aheart reshaping intervention. More particularly, this invention relatesto methods and apparatus for minimally invasive restoration of the leftventricle in patients suffering from congestive heart failure.

2. State of the Art

In the U.S., approximately 5 million patients are currently diagnosedwith congestive heart failure (CHF). CHF generally relates to adysfunction of the left ventricle. About one third of the patientssuffering from CHF have a form of CHF which results from a myocardialinfarction (MI). The Ml progressively increases the residual volume ofblood in the left ventricle, due to stagnation from decreasingcontractility of the heart muscle.

The increase in blood volume also results in an increase in leftventricular pressure which increases stress on the wall of the leftventricle. The stress requires the myocardium to work harder whichincreases oxygen demand. Since oxygen delivery to the heart has alreadybeen reduced because of coronary artery disease, the Ml and theresulting reduced ventricular output, heart muscle tissue dies and theventricle expands. This causes the myocardium to stretch, thin out anddistend, further decreasing heart performance, decreasing the thicknessof the ventricle wall and increasing wall stress.

FIG. 1 shows a normal heart 10 having right ventricle 12, left ventricle14, right atrium 16 and left atrium 18. Though not illustrated, thoseskilled in the art will appreciate that there are a pair of valvesbetween each ventricle and its associated atrium. The ventricles areseparated by an inter-ventricular septum 20. The left ventricle 14 haswhat is called a generally elliptical (ellipsoidal) shape.

FIG. 2 shows a heart 10′ suffering from CHF. The left ventricle 14′ isenlarged and assumes a circular (spherical) shape. The stress on theventricle wall is determined by the Laplace Law as illustrated inEquation 1, below. $\begin{matrix}{{{wall}{\quad\quad}{stress}} = \frac{\left( {{pressure}\quad{in}\quad{cavity}} \right) \cdot \left( {{radius}{\quad\quad}{of}\quad{cavity}} \right)}{2 \cdot \left( {{wall}\quad{thickness}} \right)}} & (1)\end{matrix}$

Thus, as wall thickness is decreased, wall stress increases. Thisincreased wall stress and oxygen demand cause a relative chronicmyocardial ischemic state which results in decreased pump function.

It has also been discovered that the change in the shape of the leftventricle adversely affects the way the heart muscle fibers work. Thenormal ellipsoidal shape most efficiently assists in blood flow throughthe left ventricle.

State of the art methods for treating CHF involve extremely invasiveopen heart surgery. For example, use of a “ventricular restorationpatch” installed via “purse string” sutures is disclosed in U.S. Pat.No. 6,544,167. The patch seals off a portion of the ventricle therebyreducing the volume and restoring the shape of the cavity. However,installation of the patch requires incision into the left ventriclewhich severs muscle fibers and the subsequent healing scar increases therisk of arrhythmia.

Another method described in U.S. Pat. No. 6,126,590 involves wrappingthe heart in a mesh and suturing the mesh to the heart. The meshconstricts both right and left ventricles, thus not allowing them tofill completely in diastole. It also may cause a constrictive effect onthe ventricles known as the tamponade effect.

Yet another method for treating CHF is described in U.S. Pat No.6,537,198 and involves the use of trans-ventricular wires anchored byexternal fixation buttons on either side of the left ventricle. Thismethod puts a compressive force on the ventricle but also results in amid-level constriction without favorably altering volume, pressure, orwall stress.

Because of the highly invasive nature of these treatments, many CHFpatients are not suitable candidates for the surgery.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide methods andapparatus for treating CHF.

It is another object of the invention to provide methods and apparatusfor reducing the volume of the left ventricle.

It is a further object of the invention to provide methods and apparatusfor restoring the left ventricular cavity to an ellipsoidal shape

It is also an object of the invention to provide minimally invasivemethods and apparatus for achieving the above objects without the sideeffects of the prior art methods and apparatus.

In accord with these objects, which will be discussed in detail below,the methods of the present invention include delivering an implantableexpandable device into the left ventricle via a catheter. The expandabledevice is anchored either to/through the wall of the left ventricle orto/through the inter-ventricular septum and then expanded. Whenexpanded, the device assumes a size and shape which fills the lowerportion of the ventricular cavity thus restoring the volume andellipsoidal shape of the remaining portion of the cavity. According toone embodiment, the device is a balloon which is expanded by filling itwith fluid such as saline. It is anchored with an anchor which extendsinto or through either the wall of the left ventricle or theinter-ventricular septum. There are two versions of the firstembodiment, one having a central stem that extends all the way throughthe balloon to its opposite end. The other has a very short stem whichjust extends into the balloon. In both cases the stem includes a valveand an inflation tube coupling. The coupling allows the inflation tubeto be coupled to and uncoupled from the balloon and the valve preventssaline from leaking out of the balloon after the tube is uncoupled fromit. A second embodiment includes a pair of umbrella-like structures, atleast one of which is covered with a biocompatible membrane and isprovided with peripheral barbs which engage the wall of the leftventricle and the inter-ventricular septum. A third embodiment utilizesa single umbrella covered with a biocompatible membrane and providedwith peripheral barbs which engage the wall of the left ventricle andthe inter-ventricular septum. In both of the umbrella embodiments anaspiration tube coupling and valve are provided. The aspiration tubecoupling allows an aspiration tube to aspirate the blood which has beensegregated from the remaining portion of the ventricle and the valveprevents blood from reentering when the aspiration tube is uncoupled.

The catheter sheath with which the device is delivered to the leftventricle includes conduit channels, ports and other means for deployingthe device, stabilizing it, anchoring it, expanding it, and disengagingfrom it. A suitable catheter for practicing the invention is one of thetype used to install heart pacing electrodes, e.g. the catheterdisclosed in U.S. Pat. No. 5,571,161 which is hereby incorporated byreference herein in its entirety.

The invention thus provides a percutaneous, intra-cardiac implantationdevice that directly reduces the amount of volume load on the leftventricle. As less volume is received in the left ventricle, theintra-cavity pressure is decreased, thereby reducing wall stress on themyocardium, decreasing oxygen demand and improving pump function. It isthe shape, volume and size of the cavity of the ventricle thatdetermines wall stress and not the external shape of the heart. Inseveral embodiments of the invention, the dimensions of the cavity ofthe ventricle are changed but not the external shape of the ventricle.In other embodiments, the dimensions of the cavity are initially changedand thereafter as ventricular remodeling occurs the external shape ofthe ventricle is also favorably altered.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptiontaken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic sectional view of a normal human heart;

FIG. 2 is a schematic sectional view of a human heart afflicted withCHF;

FIG. 3 is a schematic longitudinal sectional view of a first embodimentof an implantable expandable device in a catheter;

FIG. 3A is a schematic longitudinal sectional view of the firstembodiment of an implantable expandable device in a catheterillustrating a preferred locking mechanism between the inflation tubeand the central stem;

FIG. 4 is a schematic longitudinal sectional view of the firstembodiment being anchored to the wall of the ventricle;

FIG. 5 is a schematic longitudinal sectional view of the firstembodiment with the catheter partially withdrawn;

FIG. 6 is a schematic sectional view of the first embodiment anchoredand inflated with the catheter partially withdrawn;

FIG. 7 illustrates an alternate embodiment with a hinged anchor foranchoring to the inter-ventricular septum;

FIG. 8 illustrates an alternate embodiment with a threaded connectorrather than a snap connector;

FIG. 8A is a illustrates another embodiment similar to FIG. 8;

FIGS. 9 and 10 illustrate an alternate embodiment having a claw anchor;

FIG. 11 illustrates an alternate embodiment having a cork screw anchor;

FIG. 12 illustrates an alternate embodiment having a short stem;

FIG. 13 is a schematic perspective view of a second embodiment of animplantable expandable device;

FIG. 14 is a schematic side elevation view of the second embodimentimplanted in a ventricle;

FIG. 15 is a schematic perspective view of the cog-wheel arrangement ofthe second embodiment of the invention;

FIG. 16 is a schematic perspective view of a third embodiment of animplantable expandable device;

FIG. 17 is a schematic side elevation view of the third embodimentimplanted in a ventricle;

FIG. 18 is a schematic side elevation view of a fourth embodimentimplanted in a ventricle;

FIG. 19 is a schematic side elevation view of the fourth embodimentimplanted in a ventricle and evacuated;

FIG. 20 is a schematic side elevation view of a fifth embodimentimplanted in a ventricle;

FIGS. 21 through 23 are schematic side elevation views of a sixthembodiment being implanted in a ventricle;

FIGS. 24 through 26 are schematic side elevation views of a seventhembodiment being implanted in a ventricle;

FIGS. 27 and 28 are schematic side elevation views of an eighthembodiment being implanted in a ventricle; and

FIGS. 29 and 30 are schematic side elevation views of a ninth embodimentbeing implanted in a ventricle.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to FIG. 3, an implantable expandable device 100 is showninside a catheter sheath 102 and coupled to an inflation tube 104. Thedevice 100 includes a central shaft 106 having a distal anchor 108, aninflatable balloon 110 surrounding the shaft 106, and a proximalcoupling 112 with a self-closing valve 114. The valve 114 is in fluidcommunication with inflation ports 116. In this embodiment, the coupling112 is a snap fit to which the inflation tube 104 is removably coupled.Referring to FIG. 3A, the snap fit coupling 112 includes a male-femaletype connection. The distal end of the inflation tube 104 has a cableoperating or similar control mechanism, whereby, in a resting state, twospring loaded, lateral expansions 117 of the distal end of 104 itself,are opened to engage within the proximal end of the lumen of the centralshaft 106. To disengage, the control mechanism (a button, lever etc) atthe proximal control end (operator end) of the inflation tube 104 isactivated to pull on control wires 115, whereby, the two lateralexpansions are pulled radially inward and the snap fit into the centralshaft is released, thus separating the inflation tube 104 from thecentral shaft 106. Reengagement is accomplished by, similarly,compressing the lateral expansions first, aligning the inflation tubeand the central shaft (via fluoroscopic/ultrasound guidance) and thenallowing the lateral expansions 117 to deploy, thereby securing a fitbetween the two.

The methods of the invention include delivering the catheter sheath 102with the device 100 and inflation tube catheter 104 therein to theinterior of the left ventricle in a trans-atrial septal fashion via thefemoral vein or jugular vein. Alternatively, the device may be deliveredvia the femoral or brachial artery in a retrograde fashion through theaorta. The inflation tube 104 is then advanced relative to the cathetersheath 102 until the anchor 108 extends beyond the end of the cathetersheath 102. When entering through the jugular vein, the approach is tothe right atrium, then across the inter-atrial septum to the left atriumand through the mitral valve into the left ventricle. The anchor 108 isthen deployed into or through the apex of the left ventricle or into theseptum or through the septum into the right ventricle. FIG. 4illustrates the anchor 108 piercing the apex of the left ventricle 14′.It will be appreciated that the anchor is important to prevent balloonmigration during cardiac contractions which could otherwise result inblockage of the mitral and/or aortic valves.

In the closed (un-deployed) position, the anchor 108 resembles a dart,and is advanced into the wall of the apex or beyond the apex of theventricle or into the other ventricular cavity across theinter-ventricular septum. Once the desired position of the anchor isconfirmed (on x-ray fluoroscopy), the anchor is deployed therebypreventing removal. This anchor deployment mechanism is activated via awire passing along the catheter to the anchor either through the centralstem of the balloon or on the outside of the balloon (when the balloonis in a collapsed position). Upon twisting the central wire, a torquingmotion at its tip activates the anchor device. If the need arises toretrieve the balloon at a later date, the anchor can be reconfiguredinto a narrow dart to permit removal by twisting/untwisting (e.g.,clockwise-anti-clockwise) a mechanism at the junction of the anchor 108and the central shaft 106 of the balloon.

With the anchor 108 in place, the catheter sheath 102 is withdrawnexposing the inflatable balloon 110 as illustrated in FIG. 5. Theballoon 110 is then inflated by injecting saline (or anotherbiocompatible fluid preferably having a specific gravity equal to orless than that of blood) through the inflation tube 104 as shown in FIG.6. It is important to note the preferred shape of the balloon 110. Theshape is designed to reduce the size and also to restore the ellipsoidalshape of a healthy left ventricular cavity, and define a new ventricularapex 22′. The shape of the balloon can be described as “rotationallyasymmetric about an axis”. In the illustrated embodiment of FIG. 6 theaxis can be considered the axis of the central shaft 106. Moreparticularly, the shape is a paraboloid which is truncated at an anglerelative to its directorix thereby producing the inclined upper surfaceshown in FIG. 6. The balloon is oriented so that the inclined uppersurface preferably slopes down from the inter-ventricular septum asshown. With the high end of the upper surface positioned against theseptum, there is no impedance to contraction by the middle and upperportions of the lateral wall of the left ventricle. In addition,pressure in the balloon should be sufficient to distend the balloonappropriately and yet keep the balloon compliant enough to avoidimpeding the contraction of the myocardium.

As discussed above, the catheter 102 may be provided with a distalstabilizing configuration 103 which grips the inflation tube 104 toprevent lateral or other movement while engaging/disengaging from theballoon 110.

When the balloon 110 is expanded to the correct volume, the inflationtube 104 is decoupled from the coupling 112 (FIG. 3), as discussedabove, and the self-closing valve 114 retains the saline inside theballoon. The inflation tube 104 and the catheter sheath 102 are thenremoved from the patient's body.

It will be appreciated that different size balloons 110 may be providedso that different size hearts may be treated. The expansion of theballoon can be monitored by fluoroscopy. Alternatively, each differentsize balloon can be indicated to contain a certain volume of saline whenfully inflated. Inflation can then be monitored by metering the amountof saline which is injected into the balloon. It is presently preferredthat pre-shaped balloons be provided in volumetric increments of 10 or20 ml and that balloons range in size from 40 ml to 350 ml.

According to the preferred embodiments, the balloon 110 and anchor 108are removable via the catheter 102 and inflation tube 104. The inflationtube is preferably re-attachable to the coupling 112 should the balloonever need to be removed. When the inflation tube 104 is coupled to thecoupling 112, the self-closing valve 114 opens and allows the saline tobe suctioned, thus deflating the balloon.

The balloon is preferably soft, light weight, and compliant/compressiblein order to prevent any interference with cardiac muscle contractions.It is also non-thrombogenic, inert (e.g. made from PTFE or suitablepolyester) and impervious. It is capable of sustaining long-termimplantation. It is preferably of unitary construction and capable ofdelivery via established catheter delivery systems. Radiopaque markersmay be placed at strategic locations on the balloon and anchoringmechanisms to enable detection of the location and expansion of theballoon within the cavity during its insertion and future surveillance.Marker locations may be, for example, at the anchor, rim of the balloon,the self-closing valve, attachment/detachment location of balloon tocatheter, central injection stem, etc.

Turning now to FIG. 7, an alternate embodiment 100′ of the invention issimilar to the embodiment 100 described above with similar referencenumerals referring to similar parts. In this embodiment the centralshaft has a distal hinge 107′ which allows the anchor 108′ to be rotatedup to 90° so that it can be anchored to or through the septum 20′ orother suitable areas of the apex of the ventricle. The hinge 107′ isactivated and controlled and fixed in position by controlcables/channels or similar devices running the length of the inflationtube 104 and controlled by lever mechanisms at the operator end of thedevice. Anchoring is achieved by the central wire control system asdescribed in the other embodiments. Sufficient lateral force is achievedby torquing of the inflation tube and if necessary by stabilizing theinflation tube within the catheter sheath 102 and thereby translatingtorquing force on 102 to the hinge 107. This is an established andstandard industry method in widespread use, such as with steerablecatheters and the trans-atrial septum catheters, when such lateraltorquing motion is applied to pass through the inter atrial septum atright angles to the axis of catheter passage into the heart.

FIG. 8 shows yet another alternate embodiment 100″ which is similar tothe embodiment 100 described above with similar reference numeralsreferring to similar parts. The difference here is that the coupling112″ between the inflation tube 104″ and the central shaft 106″ is arotational locking mechanism, such as a threaded coupling or a luerlock, with the inflation tube catheter 104 and central shaft 106deployed in precoupled state. When adequate anchor to the apex andinflation of the balloon 110″ is confirmed, the inflation tube and thecentral shaft are disengaged by a counter-clockwise torque motion of theinflation tube 104″.

In order to facilitate torquing motion of the inflation tube 104″, thedistal end of the catheter sheath 102″ may be also provided with aconstricting mechanism which couples the catheter sheath and inflationtube catheter together for application of torquing motion to theinflation tube by the catheter sheath. For example, control wires 118″may be coupled to compressible elements such as leaves or pincers 121″at the distal end of the catheter sheath 102″ producing agrasping/gripping effect, or a Teflon/ PTFE cuff can be inflated at orpurse-string coupled to the distal end of the catheter sheath. Thesemechanisms serve to stabilize the central shaft 106″ or the distal endof the inflation tube catheter 104″ for disengagement or reengagement asneeded, and while the torquing motion is applied.

FIG. 8A shows a similar embodiment to FIG. 8, wherein the central shaft106 a″ at its proximal alignment end to the inflation tube 104 a″ ispreferably slightly longer than its balloon 110 a″ component so thatenough purchase is afforded to the catheter sheath 102 a″ stabilizingmechanism to act upon. FIGS. 9 and 10 illustrate another alternateembodiment 100′″ which is similar to the embodiment 100 described abovewith similar reference numerals referring to similar parts. Thedifference here is that the anchor 108′″ is a group of claws. After theapparatus 100′″ is delivered to the ventricle, the claws are opened asshown in FIG. 9. The claws are brought into engagement with the insidewall of the ventricle at the apex or the septum. After an adequateamount of myocardial tissue is grasped between the claws, they areclosed as shown in FIG. 10.

More particularly, the anchor claws 108′″ are aligned around theperiphery of a cog wheel arrangement, the center of which has an openingfor passage and insertion of the aligning end of the central wire passedthrough the inflation tube. The central wire is inserted into the lumenof the cog wheel arrangement and a torquing clockwise motion opens thecog wheel and the claws, and a counterclockwise motion closes it. Afterthe desired effect, the central wire maybe withdrawn. Claws deployableinto cardiac tissue and mechanisms for their deployment and release arewell known to individuals skilled in the art of cardiac active pacingleads.

FIG. 11 illustrates another alternate embodiment 100″″ which is similarto the embodiment 100 described above with similar reference numeralsreferring to similar parts. The difference here is that the anchor 108″″is a “cork screw” which is controlled by a wire passing through thecentral shaft 106″″. Alternatively, the cork screw may be threaded intothe wall by a twisting motion of the whole catheter and central shaftwithout need for a central wire. Alternatively, the corkscrew may bethreaded into the anchor site by stabilizing, fixing and immobilizingthe distal end of the catheter sheath on the inflation tube and centralshaft, thus making all three of these components into one single rigidtorque tube.

FIG. 12 illustrates another alternate embodiment 100′″″ which is similarto the embodiment 100 described above with similar reference numeralsreferring to similar parts. The difference here is that the centralshaft 106′″″ is relatively shorter and does not extend through to theanchor 108′″41 after the balloon 110′″″ is inflated.

Turning now to FIGS. 13 and 14, a second embodiment 200 of the device ofthe invention includes a catheter sheath 202 and a deployment/suctiontube 204. In lieu of an inflatable balloon, this embodiment has twospaced apart biocompatible umbrellas 206, 208 which are each coveredwith a biocompatible membrane 210, 212. The periphery of each umbrellais provided with barbs 214, 216 which are located on the ends of radialspokes 215, 217, and the umbrellas are coupled to each other by asemi-rigid stem 218 which is provided with aspiration ports 220. The topof the stem 218 has a coupling 222 for removably coupling to the end ofthe tube 204. The coupling 222 includes a valve which automaticallyseals the passage into the stem 218 when the tube 204 is decoupled fromit. Clock-wise or anti-clockwise rotation of the tube 204 (when coupledto the stem 218) produces an expanding or retracting motion on theradial spokes of the umbrellas. The articulating part of the catheterand the umbrella spoke attachments have a cog wheel configurationlinkage that allows torque motion which opens or closes the umbrellas.

More particularly, referring to FIGS. 13-15, the distal tip of the stem218 (anchor end) and the distal tip of the tube 204 have circular cogwheel arrangements 226, which fit into complimenting recesses 228 inhubs 230 of the radial spokes of the distal and proximal umbrellas 206,208. The device is pre-assembled in this fashion. Upon deployment of theanchor mechanism, the catheter sheath 202, tube 204, and the centralshaft 218 are fixed by the stabilizing mechanism of the catheter sheathinto a rigid component that torques the distal cog wheel 226 and theproximal cog wheel (not shown) such that it rotates clockwise the hub228 of the radiating spokes, which expands the umbrellas 206, 208 andcauses engagement of the barbs 214, 216 upon expansion to anchor theumbrellas. Now, the proximal end of the central shaft is disengaged fromthe inflation tube, and the stabilizing mechanism of the catheter sheathis deactivated, thus leaving the deployed umbrellas with theirconnecting central shaft in place inside the heart cavity. It will beappreciated from the figures that one umbrella is upside down and theother is right side up. The upside down umbrella 208 engages the apex ofthe ventricle and expands less and/or is smaller that the other umbrella206.

The catheter, tube and umbrellas are delivered to the left ventriclewith the umbrellas closed and inside the catheter. The umbrellas arepushed out of the catheter either by pulling back on the catheter whileholding the tube or pushing forward on the tube while holding thecatheter. The umbrellas are then opened until their barbs engage theventricular wall and septum as shown in FIG. 4. Blood trapped betweenthe umbrellas is aspirated via the ports and the tube. The vacuum usedto aspirate also causes the umbrellas to further engage the ventriclewall and septum.

FIGS. 16 and 17 illustrate a third embodiment 300 which is similar tothe second embodiment just described. It includes a catheter 302, adeployment/aspiration tube 304, and an umbrella 306. The umbrella iscovered with a biocompatible membrane 310. The periphery of the umbrellais provided with barbs 314 and the center of the umbrella is providedwith a valved coupling 322. The valved coupling 322 allows the tube 304to couple and uncouple from the umbrella. When the tube 322 is coupledto the umbrella, rotation of the tube causes the umbrella to open orclose, as discussed above. After the umbrella is deployed, blood trappedbetween the apex of the ventricle and the umbrella is aspirated throughthe tube 304 and the tube is then uncoupled from the umbrella. Atuncoupling, the valve 322 closes and prevents blood from reentering thespace between the apex of the ventricle and the umbrella. Anotheralternate (non-illustrated) embodiment is similar to the embodiment 300but includes a central stem extending from the center of the umbrella tothe apex of the ventricle with an anchor at its tip.

Turning now to FIG. 18, another embodiment of device for percutaneousventricular restoration is shown. The device 400 includes a balloon 410with a central perforate stem 406. The balloon 410 is coupled at theapex of the left ventricular substantially as described above, with ananchor 408. The sides of the balloon 410 include an abrasive and/orporous surface 416 preferably provided with an irritant coating 418,such as tetracycline or bleomycin or other such sclerosing agent. Suchsurface 416 and coating 418 enhances adhesion of the balloon 410 to theventricular wall and promotes ingrowth of fibrous tissue from theventricular wall onto the balloon. Inflation fluid 420 is deliveredthrough a delivery tube (not shown) and valve 414 to expand the balloonwithin the apex of the ventricle so that the porous surface is incontact with the heart wall tissue. The expanded balloon, as shown inFIG. 18, is left in place for a period of time, e.g., eight to twelveweeks, to allow such ingrowth and tissue-to-balloon adhesion. Then,after the period of time required for tissue ingrowth, the patientundergoes a subsequent procedure during which the inflation fluid ispercutaneously removed from the balloon by re-coupling a tube at thevalve 414 and applying suction. Referring to FIG. 19, as the balloon 410is evacuated and collapsed its volume is reduced, the diameter of theballoon decreases, thereby reshaping the ventricular cavity by causingmovement of the left ventricular wall and the septum toward each other.Thus, not only the shape and size of the cavity of the ventricle isrestored, but the external shape of the ventricle is also favorablyaltered. In an alternate embodiment, the top surface of the balloon maybe thicker and non-compliant relative to the sides of the balloon, e.g.,provided with stiffening ribs. Then, upon evacuation of the balloon,reshaping is limited to the sides of the balloon (rather than its topsurface), maximizing movement of the lateral ventricular wall toward theseptum.

Referring to FIG. 20, the wall 516 of the balloon 510 may be providedwith a porous trabeculae or lattice 518 that forms a thin wall chamber520 that is communicable with a suction source tube 522 applied at valve514. By rotating suction source tube 522 relative to the valve 514suction may be selectively applied to the interior of the balloon 524 orthe chamber 520. Upon application of suction to the balloon wall chamber520, the perforate outer surface of the balloon wall 516 adheres to theventricular wall by way of negative pressure. The negative pressure canbe maintained on the wall even after the active application of negativepressure is discontinued, creating adhesion similar to that created by asuction cup. In use, the balloon is inflated at the apex as described inprior embodiments to provide good balloon wall/tissue contact. Then,suction adhesion is created between the balloon wall and the ventricularwall. After suction adhesion is effected, the balloon may be evacuatedof fluid by application of suction to the interior of the balloon. Suchwill reduce weight in the left ventricle in addition to reducing volume.

Turning now to FIGS. 21 to 23, another embodiment of a percutaneousdevice for modifying the volume of the left ventricle of the heart isshown. Referring to FIG. 21, the device is initially inserted as aballoon 610 anchored to the apex and about its upper surface,substantially as previously shown and described. The balloon ispreferably, but not necessarily, inflated. Referring to FIG. 22, thenthrough valve 614, a delivery device 624 provided with a collapsedbasket 626 at its distal end is inserted into the interior of theballoon 610. The basket 626 is preferably spring-loaded to self expandto the interior periphery of the balloon upon retraction of a coveringsheath (not shown). After basket insertion, the delivery device is thenoperated to retract the covering sheath to allow the basket to expandand decouple the basket into the interior of the balloon. Alternatively,the basket may be made from a shape memory alloy that can be activatedto assume an expanded configuration upon application of heat or otherenergy, and the delivery device is then configured and operated toactivate the basket to reconfigure from a collapse state into anexpanded state once inserted into the balloon. Referring to FIG. 23,after expansion of the basket 626, if fluid is initially used to inflatethe balloon 610, the fluid may be evacuated coupling a tube 622 to valve614 and applying appropriate suction to the interior of the balloon.

Turning now to FIGS. 24 to 26, another embodiment of a percutaneousdevice for modifying the volume of the left ventricle is shown. Thedevice 700, provided at the distal end of a delivery instrument 724, isinitially in the form of a radially collapsed wire basket 726 within aballoon 710. An outer sheath 728 confines the device 700 to thecollapsed state (FIG. 24). The device 700 is delivered to the apex ofthe left ventricle and coupled thereat. Referring to FIG. 25, then theouter sheath 728 is retracted causing the device 700 to expand withinthe apex of the left ventricle. Finally, referring to FIG. 26, thedelivery instrument 724 is decoupled from the device 700 and removedfrom the heart.

Turning now to FIGS. 27 and 28, the volume of the left ventricle mayalso be reduced in a non-percutaneous, but relatively minimally invasiveapproach via a sub-xiphoid incision or through a thoracoscope 832 via aleft anterior thoracotomy incision. A delivery device 830 including anintroducer 822, a balloon 810 preferably substantially similar to one ofthe embodiments described above at the distal end thereof, and aretractable sheath 828 over the balloon is advanced to the apex of theheart through the selected approach. The distal end of the deliverydevice 830 is inserted trans-apically into the left ventricle. Theapical side of the balloon 810 includes an anchor 808 with an inflationvalve 814. The balloon 810 is inflated through the inflation valve 814and the anchor 808 is then pulled back through the apex of the heartwall. The anchor 808 is preferably locked to the wall with a button 809or other suitable fastener. The anchor and button may be reliablycoupled permitting removal of the balloon if necessary. A preferredattachment includes a releasable ratchet mechanism. The button 809 maybe introduced over the introducer 822 and seated prior to releasing theintroducer from the balloon 810, or the introducer may be released fromthe balloon and the button attached thereafter.

Referring to FIGS. 29 and 30, another minimally invasive embodiment isshown and now described. A balloon 910 is delivered trans-apically intothe left ventricle. The balloon 910 has a valve 914 at its apical side.A collapsed basket 916 is introduced on a delivery device 922 into theballoon 910 and then expanded. The basket 916 may be self-expanding orcomprised of a shape memory alloy expandable via application ofappropriate energy. If energy is required, the delivery device 922 alsoincludes an energy applicator to deliver the required energy for basketexpansion. The apical end of at least one of the balloon and the basketincludes an anchor 908, optionally for receiving a button 909, to couplethe balloon/basket within the left ventricle. Such anchor 909additionally comprises the site for energy reception to expand thebasket, if necessary. Alternatively, the balloon 910 and basket 916 canbe introduced together, as discussed above, into the left ventricletrans-apically.

There have been described and illustrated herein several embodiments ofapparatus and a methods for ventricular restoration. While particularembodiments of the invention have been described, it is not intendedthat the invention be limited thereto, as it is intended that theinvention be as broad in scope as the art will allow and that thespecification be read likewise. Thus, while particular anchors have beendisclosed, it will be appreciated that other anchors could be used aswell. For example, a simple bayonet anchor could be used. In addition,while the presently preferred embodiment of the balloon has beendescribed as a truncated paraboloid with the truncation plane at anangle to the directorix plane, other shapes could be used provided theyyield equivalent results. For example, and not by way of limitation, thetop surface of the balloon could be concave, convex, flat or angled.Other types of couplings between the inflation tube and the ballooncould also be used, e.g. a bayonet coupling. Also, while the termballoon has been used, it is not necessary that the balloon be made ofan elastic element, but such balloon should be made of a materialrelatively impermeable to the fluid (saline, blood) that must be kept inand/or out of the interior of the balloon for the given embodiment. Itwill therefore be appreciated by those skilled in the art that yet othermodifications could be made to the provided invention without deviatingfrom its scope as claimed.

1. An apparatus for cardiac ventricular restoration, comprising: aballoon constructed in a size and shape which permit it to be deliveredto an interior of the ventricle in an unexpanded state and beingconstructed to permit it to be expanded once it has been delivered tothe interior of the ventricle; and an anchoring device coupled to theballoon and having structure which permits it to anchor the balloon tothe ventricular wall or the ventricular septum.
 2. The apparatusaccording to claim 1, wherein: said balloon in an unexpanded state issized to be delivered percutaneously into the heart.
 3. The apparatusaccording to claim 2, further comprising: a delivery device havingstructure which permits it to deliver the balloon in the unexpandedstate through a blood vessel to the interior of the ventricle; andexpanding means for expanding the balloon after the balloon is in theinterior of the ventricle.
 4. The apparatus according to claim 1,further comprising: an attachment device having structure which permitsthe attachment device to attach the anchoring device to the ventricularwall or the ventricular septum.
 5. The apparatus according to claim 4,wherein: the attaching device and the expanding means are integral witheach other.
 6. The apparatus according to claim 1, wherein: the deliverydevice includes a catheter, and the expanding means includes a tubeextending through the catheter.
 7. The apparatus according to claim 1,wherein: the anchoring device includes at least one of a barb, screw ora claw.
 8. The apparatus according to claim 1, wherein: the anchoringdevice includes a post and button assembly.
 9. The apparatus accordingto claim 8, wherein: said post and button are releasable from eachother.
 10. The apparatus according to claim 1, wherein: said balloon hasa centrally located stem with at least one inflation port.
 11. Theapparatus according to claim 10, wherein: said stem extends through theballoon from one end thereof to an opposite end thereof.
 12. Theapparatus according to claim 10, wherein: the stem extends onlypartially into the balloon.
 13. The apparatus according to claim 9,wherein: the anchoring device is coupled to the stem.
 14. The apparatusaccording to claim 9, wherein: said stem includes a coupling devicehaving structure which permits it to couple to an inflation tube and avalve which automatically closes when the inflation tube is uncoupledfrom the coupling device.
 15. The apparatus according to claim 1,wherein: said expanding means is a basket.
 16. The apparatus accordingto claim 15, wherein: said basket is self-expanding.
 17. The apparatusaccording to claim 15, wherein: said basket is expandable upon theapplication of heat energy.
 18. The apparatus according to claim 1,wherein: said balloon includes a perforate outer surface and inner andouter chambers, said outer surface in communication with said outerchamber, wherein when fluid is injected into and removed from said innerchamber said volume of said balloon is modified, and when suction isapplied to said outer chamber negative pressure is applied at saidperforate outer surface.
 19. A system for percutaneous ventricularrestoration, comprising: expandable means that can be configured tochange in volume when within a ventricle of the heart; delivery meansfor percutaneously delivering the expandable means to the ventricle;means for permanently securing the expandable means within theventricle; and expansion means for expanding the expandable means whenthe expandable means is located within the ventricle.
 20. A method forventricular restoration of the heart, comprising: permanently implantinga volume-changing device within a ventricle of the heart; and expandingthe volume-changing device so as to reduce the available blood volume ofthe ventricle.
 21. A method according to claim 20, further comprising:prior to permanently implanting, the volume-changing device is deliveredto the ventricle with a delivery device; and separating the deliverydevice from the expandable device.
 22. A method according to claim 20,wherein: said permanently implanting includes delivering and implantingthe volume-changing device in a minimally invasively procedure.
 23. Amethod according to claim 20, wherein: said permanently implantingincludes delivering and implanting the volume-changing devicepercutaneously.
 24. A method according to claim 20, wherein: saidimplanting and expanding occur without significantly changing theexternal shape of the heart.
 25. A method according to claim 20, furthercomprising: reducing the size of the volume-changing device so as toeffect a change in the external shape of the heart.